Evaluation of Prevalence and Risk Factors of Persistent COVID-19 in Immunocompromised Patients

NCT06576102 | Active Not Recruiting

• 1 other identifier: PERsiCO
• Study Type: observational
• Target: 204
• Locations: 2 countries
• Sites: 5

Brief Summary

Spontaneous international multicenter retrospective and prospective observational study which objective is to evaluate the prevalence and risk factors of persistent SARS-CoV-2 infection within a population of hematology patients with humoral immunity deficiency.

Conditions

Persistent COVID-19; B Cell Malignancies

Keywords

COVID-19; Persistent SARS-CoV-2 infection; Immunocompromised patients; B cell malignancies; B cell targeting therapies; viral infections in the hematological patient

Outcome Measures

Primary Outcomes (1)

• Prevalence of persisting SARS-CoV-2 infection among immunocompromised patients

  The first primary endpoint variable will be the rate of patients with persisting SARS-CoV-2 infection among study patients with new diagnosis of SARS Cov2 during the study period Persisting COVID19 will be defined as the persistence or the recurrence of symptoms and signs (fever, dyspnea, hypoxemia, changes on chest-X ray or CT scan) and positive SARS-CoV-2 PCR ≥ 21 days after the time 0 (day of the first test positive for SARS-CoV-2 infection)

  Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals

Secondary Outcomes (6)

• Risk factors for persisting COVID19

  Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals

• Duration of viral shedding

  Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals

• Duration of symptoms

  Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals

• Prevalence of imaging alterations

  Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals

• Re-infection within 120 days

  Retrospective recruitment period will span from January 1st, 2022 to to the date of authorisation by hospital directorates following the Ethics Committees' approvals

Study Arms (1)

Patients with B cell malignancies

All immunocompromised adults (≥18 years) with a new SARS-CoV-2 infection assessed during the study period, hospitalized or followed as outpatients in the participating centers, will be screened for inclusion. Inclusion Criteria: * Diagnosis of B cell malignancies or previous treatment with B cell targeting therapies. * Diagnosis of proven SARS-CoV-2 infection confirmed by a PCR test (only the first infection during the study period will be considered, re-infection will be counted as a secondary endpoint).

Other: Persisting SARS-CoV-2 infection

Interventions

Persisting SARS-CoV-2 infection OTHER

Prevalence of persisting SARS-CoV-2 infection among immunocompromised patients defined as the persistence or the recurrence of symptoms and signs (fever, dyspnea, hypoxemia, changes on chest-X ray or CT scan) and positive SARS-CoV-2 PCR ≥ 21 days after the time 0 (day of the first test positive for SARS-CoV-2 infection)

Patients with B cell malignancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All immunocompromised adults (≥18 years) with a new SARS-CoV-2 infection assessed during the study period, hospitalized or followed as outpatients in the participating centers, will be screened for inclusion.

You may qualify if:

• Diagnosis of B cell malignancies or previous treatment with B cell targeting therapies.
• Diagnosis of proven SARS-CoV-2 infection confirmed by a PCR test (only the first infection during the study period will be considered, re-infection will be counted as a secondary endpoint).
• Provision of signed and dated informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• Maddalena Giannella: lead

Study Sites (5)

Irccs Aoubo

Bologna, 40138, Italy

Location

IRCCS Humanitas

Milan, 20089, Italy

Location

IRCCS INMI L. Spallanzani

Roma, 00149, Italy

Location

AOUI Verona

Verona, 37126, Italy

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maddalena Giannella, MD PhD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 28, 2024
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

IT (4); ES (1)